Innovating Endpoints in IPF: Including & Beyond FVC to Determine Clinical Efficacy

FVC remains the standard endpoint for IPF clinical trials, yet its variability poses challenges for trial reliability, cost, and regulatory approval. As the field advances, there is a growing need to refine clinical trial endpoints by integrating additional, more predictive measures. This workshop will explore innovative approaches to endpoint selection, incorporating lessons from other respiratory diseases and data-driven strategies to enhance trial sensitivity and efficiency.

Get ready to explore:

Addressing the Limitations of FVC

  • Understanding the variability of FVC, its impact on trial design, and the need for complementary or alternative measures to improve accuracy and trial success

Learning from Composite Endpoints in Pulmonary Arterial Hypertension

  • Evaluating how composite endpoints, including six minute walk distance, respiratory hospitalizations, and imaging biomarkers, can provide a more robust efficacy assessment

Advancing Clinical Trial Design

  • Leveraging quantitative, data-driven approaches to define novel composite endpoints that enhance sensitivity, support regulatory approval, and transform the future of IPF clinical trials